DALBAVANCIN for Catheter-related bloodstream infection due to Staphylococcus aureus

Inclusion criteria

• {"criterion_text":"- Patients aged at least 18 years"}
• {"criterion_text":"- First blood culture positive for S. aureus, obtained within 96 hours before randomization (the date considered is the date of the sampling, not the results)"}
• {"criterion_text":"- CR-BSI, defined as: o\tOne positive blood culture AND Local signs of infection at the catheter site OR o\tat least one positive blood culture obtained from the catheter and the peripheral vein, AND o\tA differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended; AND o\tSame S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures; OR o\tOne positive blood culture AND o\tStrong presumption of catheter-related infection according to clinical opinion"}
• {"criterion_text":"- Intravascular catheter – implantable venous access device (port-a-cath and Piccline) – removed before randomization"}
• {"criterion_text":"- Informed consent form date and signed by the patient"}

Exclusion criteria

• {"criterion_text":"- Polymicrobial BSI (Bloodstream infection)"}
• {"criterion_text":"- Severe liver disease (Child-Pugh C)"}
• {"criterion_text":"- Severely immunocompromised patients: o\tNeutropenia (< 500 neutrophils/µL) at randomization; o\tHematopoietic stem cell transplantation within the past 6 months or planned during treatment period; o\tSolid organ transplant;"}
• {"criterion_text":"- Contraindication to dalbavancin and/or glycopeptid"}
• {"criterion_text":"- Life expectancy < 3 months"}
• {"criterion_text":"- Active injection drug user"}
• {"criterion_text":"- Pregnant or breastfeeding women"}
• {"criterion_text":"- For premenopausal women: failure to use highly-effective contraceptive methods for 1 month after receiving study drug"}
• {"criterion_text":"- Participation in other interventional trials ongoing on antibiotic treatment (participation in another interventional trial not involving antibiotic treatment may be authorized after verification of the absence of interference between the two trials in terms of safety and methodology);"}
• {"criterion_text":"- Persons held in an institution by legal or official order, Patients under legal protection, Patients under guardianship or curatorship;"}
• {"criterion_text":"- Patients unable to give a free and informed consent"}
• {"criterion_text":"- Dalbavancin resistant strain (A strain sensitive to vancomycin or methicillin (by culture or molecular method) is considered sensitive to dalbavancin)"}
• {"criterion_text":"- Patient not affiliated to a social security scheme: obligation of affiliation to a social security scheme or to be a beneficiary."}
• {"criterion_text":"- More than 96 hours of active antibiotic treatment targeting S. aureus (in-vitro susceptibility) administered prior to randomization"}
• {"criterion_text":"- Patient with known valvulopathy at risk of endocarditis according to the clinician, previous history of endocarditis, or suspicion of infective endocarditis by physician in charge"}
• {"criterion_text":"- Suspicion of any other deep focus infections, such as arthritis, pneumonia, osteomyelitis, or meningitis, presence of cerebral or peripheral emboli (arterial occlusion)"}
• {"criterion_text":"- Thrombophlebitis clinical or clinically significant"}
• {"criterion_text":"- Failure to remove any intravascular catheter which was present when first positive blood culture"}
• {"criterion_text":"- Signs of infection associated with qSOFA score ≥ 2 at randomization"}
• {"criterion_text":"- Patients with foreign bodies such as: prosthetic heart valve, endovascular prosthesis, ventriculo-atrial shunt, pacemaker, or an automated implantable cardioverter defibrillator (AICD) device"}

Primary endpoints

• {"endpoint_text":"- Clinical cure without relapse at Day 30, defined by the absence of all the following: Local and/or general signs of infection, Relapse of bacteremia to S. aureus ; In dalbavancin arm: Any additional antibiotic therapy active on S. aureus received between DAY 0 and DAY 14 \tIn both arms: Any additional antibiotic therapy active on S. aureus received after DAY 14; i.e. between DAY 14 and DAY 30, Deep focus infection including endocarditis, Death from all causes","definition_or_measurement_approach":"Assessment at Day 30 (Long follow up visit); clinical cure without relapse is defined by absence of listed items (local/general signs of infection, relapse of S. aureus bacteremia, receipt of additional active antibiotics in specified windows, occurrence of deep focus infection including endocarditis, or death from any cause) evaluated at Day 30."}

Secondary endpoints

• {"endpoint_text":"- Clinical cure at DAY 14 and DAY 90 (EOS)","definition_or_measurement_approach":"Assessment of clinical cure at Day 14 and at end of study (Day 90)."}
• {"endpoint_text":"- Death all-cause occurring within 90 days of follow-up","definition_or_measurement_approach":"All-cause mortality monitored through Day 90."}
• {"endpoint_text":"- Time from first positive blood culture to first negative blood cultures (in days), limited to DAY 14","definition_or_measurement_approach":"Measured in days from date of first positive blood culture to first documented negative blood culture up to a maximum of Day 14."}
• {"endpoint_text":"- Autonomy, pain and anxiety using EQ-5D-5L scale at baseline (Day 0), DAY 14, DAY 30 and DAY 90 (EOS)","definition_or_measurement_approach":"Patient-reported outcomes using EQ-5D-5L assessed at baseline, Day 14, Day 30 and Day 90."}
• {"endpoint_text":"- Hospitalization duration in days","definition_or_measurement_approach":"Length of hospital stay measured in days."}
• {"endpoint_text":"- Cost per avoided relapse, life-year gained, and per quality-adjusted life year (QALY)","definition_or_measurement_approach":"Health economic outcomes (cost-utility analyses) including cost per avoided relapse, cost per life-year gained, and cost per QALY."}
• {"endpoint_text":"- Proportion of patients with any adverse event until EOS. It includes the complications due to venous catheterization","definition_or_measurement_approach":"Safety monitoring: proportion of patients experiencing any AE or SAE from inclusion until end of study (Day 90), including catheterization-related complications."}

France

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

595

Number Of Sites

34

Number Of Participants

406

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France